The purpose of this study is to evaluate ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) in participants with chronic genotype 1 or 4 hepatitis C virus (HCV) infection. Participants will be randomized to receive 12 or 24 weeks of dosing with the LDV/SOF FDC tablet+ribavirin (RBV).

A Phase 2, Multicenter, Open-Label Study to Investigate the Safety and Efficacy of Sofosbuvir/Ledipasvir Fixed-Dose Combination + Ribavirin Administered in Subjects Infected With Chronic HCV Who Have Advanced Liver Disease or Are Post-Liver Transplant

For those participants who have a liver transplant while on study, the proportion of participants with post-transplant virologic response (PTVR, defined as HCV RNA < LLOQ at 12 weeks post-transplant) will be summarized for participants in the Full Analysis Set (FAS) who have HCV RNA < LLOQ at their last observed HCV RNA prior to transplant.

Cohort B, post-transplant Group 3. Participants without cirrhosis (fibrosis stage F0-F3) and with no evidence of hepatic decompensation will be randomized to receive either 12 or 24 weeks of LDV/SOF plus RBV.

Cohort B, post-transplant Group 7. Participants with aggressive recurrent disease after transplant with evidence of cholestasis (fibrosing cholestatic hepatitis [FCH]) will be randomized to receive either 12 or 24 weeks of LDV/SOF plus RBV.

Male subjects and female subjects of childbearing potential must agree to use contraception

Able to comply with the dosing instructions for study drug and able to complete the study schedule of assessments, including all required post treatment visits

Exclusion Criteria

Serious or active medical or psychiatric illness

HIV or hepatitis B viral (HBV) infection

Stomach disorder that could interfere with the absorption of the study drug

Treated with an anti-HCV medication in the last 30 days

Any prior exposure to an HCV nonstructural protein (NS)5a-specific inhibitor

Use of human granulocyte-macrophage colony-stimulating factor (GM-CSF), epoetin alfa or other therapeutic hematopoietic agents within 2 weeks of screening

History of clinically significant medical condition associated with other chronic liver disease

Active spontaneous bacterial peritonitis at screening

Females who are breastfeeding

Infection requiring systemic antibiotics

Participated in a clinical study with an investigational drug or biologic within the last 30 days

Active or history (last 6 months) of drug or alcohol abuse

History of organ transplant other than liver or kidney

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01938430